Operations Technician

The future of healthcare is here. Join us to shape the future of healthcare for patients and clinicians. BioIntelliSense is helping to decode human physiology and pioneer a new standard of proactive monitoring to improve healthcare outcomes and save lives.

Our FDA-cleared and award-winning BioButton® multiparameter wearables, BioHub™ gateways, BioMobile™ downloadable applications, BioCloud™ data services and the BioDashboard™ clinical intelligence system creates a comprehensive tech-enhanced solution that makes continuous monitoring reliable and scalable. Through our physiologic intelligence and AI-driven analytics, clinicians have access to high-resolution vital sign trending and data-driven insights to enable earlier detection of patient deterioration and proactive intervention for better, safer care.

We’re a remote-first, lean start-up environment and our global BioTeam colleagues are growth-oriented, collaborative and passionate about our mission and the future of BioIntelliSense. We thrive in a fast-paced environment and embrace challenges as opportunities to shape the future, together.

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Responsibilities

• Complete daily tasks in accordance withBioIntelliSense Policies and Procedures, including the safety rules and regulations
• Must follow Good Documentation Practices (GDP)
• Conduct testing of electronic medical devices per procedure and document results
• Set-up computer driven test equipment and supporting processes
• Create procedures to document the test process
• Run diagnostics and calibrations
• Conduct experiments and investigations under the guidance of Engineers
• Inspect inventory and reordering materials and technical components
• Analyzing operations and offering suggestions for improvement
• Maintain detailed and accurate records
• Support and follow all ISO 13485 and FDA regulations and standards
• Perform general 5S activities daily
• Perform other duties and requests, as assigned
• Understand and apply product traceability
• Perform packaging and labeling
• Ability to work independently
• Ability to lead and positively influence others in a team-based environment

Experience

• Previous manufacturing experience preferred
• Previous experience in an FDA and/orISO 13485 regulated environment preferred
• Knowledge and use of relevant computer software applications and skills to use them effectively
• Sound understanding of electronics technology
• Extensive experience running computer driven test set-ups
• Excellent attention to detail and organizational skills
• Ability to collaborate and remain calm and professional in a fast-paced environment
• Strong communication, writing and presentation skills
• A willingness to learn and work overtime when required
• Ability to adapt to a dynamic environment
• Ability to read and write in English is required

Physical Requirements

• Job duties are performed in a warehouse setting. This position requires reading, hearing, close vision, walking, bending, sitting, and occasional lifting up to 50 pounds.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Job Responsbilities

• Complete daily tasks in accordance with BioIntelliSense Policies and Procedures, including the safety rules and regulations
• Must follow Good Documentation Practices (GDP)
• Responsible for work order ticket prioritization for the Service and Fulfillment team and ensuring tickets are completed on-time and with no failures
• Working alongside engineers to build and test solutions to a variety of technical problems
• Inspecting and modifying existing designs and prototypes
• Conduct tests, collect data, and record the data clearly and accurately
• Analyze operations and offer suggestions for improvement
• Maintain accurate records and assist with data collection for metrics and presentations
• Set-up computer driven test equipment and supporting processes
• Create procedures to document the test process
• Conduct inspection of devices.
• Run diagnostics and calibrations
• Inspect inventory and reordering materials and technical components
• Support and follow all ISO 13485 standards
• Perform general 5S activities daily
• Identify and report non-conforming material and product
• Apply product traceability
• Perform packaging and labeling duties
• Retrieve information, train and transfer knowledge to team members
• Lead and positively influence others in a team-based environment
• Align with BioIntelliSense’s mission, values and leadership principles
• Other duties and special projects as assigned

Job Requirements

• 2-3 years of manufacturing and inspection experience within the medical device industry preferred
• Previous experience in an FDA and/or ISO 13485 regulated environment preferred
• Knowledge and use of relevant computer software applications and skills to use them effectively
• Sound understanding of electronics technology
• Extensive experience running computer driven test set-ups
• Excellent attention to detail and organizational skills
• Ability to work independently but also collaborate and remain calm and professional in a fast-paced, dynamic environment
• Strong communication, writing and presentation skills; Ability to read and write in English is required
• A willingness to learn and work overtime when required
• Able to foster a positive culture and collaborate cross functionally while advancing BioIntelliSense as a great place to work

Physical Requirements

• Job duties are performed in a warehouse setting. This position requires reading, hearing, close vision, walking, bending, sitting, and occasional lifting up to 50 pounds.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.